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PTC Therapeutics' (PTCT) PKU Drug Meets Study Goal, Up 7.6%
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Shares of PTC Therapeutics (PTCT - Free Report) were up 7.6% on May 17, after management announced that the phase III APHENITY study, evaluating sepiapterin in adult and pediatric patients with phenylketonuria (“PKU”), achieved its primary endpoint of reduction in blood phenylalanine (“Phe”) levels.
Data from the APHENITY study showed that patients who were treated with sepiapterin achieved a mean blood Phe reduction of 63%. These results were statistically significant when compared to those patients who were administered placebo, demonstrating the drug’s treatment benefits.
Based on the above data, management will begin discussions with regulatory authorities to discuss the path for a potential regulatory approval.
In the year so far, shares of PTC Therapeutics have surged 52.7% against the industry’s 1.0% fall.
Image Source: Zacks Investment Research
PKU is a rare genetic enzyme deficiency disorder, caused by defect in the gene that help creates the enzyme needed to break down Phe. If left untreated, a build-up of Phe can lead to severe and irreversible disabilities, like permanent intellectual disability, seizures, delayed development, memory loss and behavioral and emotional problems. Per management, nearly 58,000 people across the globe suffer from PKU.
If sepiapterin were to be approved, it would face stiff competition from BioMarin Pharmaceuticals (BMRN - Free Report) , which already markets medications in the PKU space. BioMarin’s portfolio consists of two medications, namely Kuvan and Palynziq, which are approved by the FDA to lower blood Phe levels in a certain type of PKU. Currently, BioMarin is facing generic erosion for Kuvan in the United States, hurting its topline significantly.
PTC Therapeutics currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include ANI Pharmaceuticals (ANIP - Free Report) and Allogene Therapeutics (ALLO - Free Report) . While ANI Pharmaceuticals sports a Zacks Rank #1 (Strong Buy), Allogene carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2023 earnings per share have increased from $2.42 to $3.31. During the same period, the earnings estimates per share for 2024 have risen from $3.76 to $4.32. Shares of ANI Pharmaceuticals are up 10.6% in the year-to-date period.
Earnings of ANIP Pharmaceuticals beat estimates in each of the last four quarters, delivering an average earnings surprise of 68.64%. In the last reported quarter, ANI Pharmaceuticals’ earnings beat estimates by 244.12%.
In the past 60 days, estimates for Allogene Therapeutics’ 2023 loss per share have improved from $2.50 to $2.32. During the same period, the loss estimates per share for 2024 have narrowed from $2.48 to $2.21. Shares of Allogene Therapeutics have declined 2.7% in the year-to-date period.
Earnings of Allogene Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a surprise of 5.08%. In the last reported quarter, Allogene Therapeutics’ earnings beat estimates by 7.94%.
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PTC Therapeutics' (PTCT) PKU Drug Meets Study Goal, Up 7.6%
Shares of PTC Therapeutics (PTCT - Free Report) were up 7.6% on May 17, after management announced that the phase III APHENITY study, evaluating sepiapterin in adult and pediatric patients with phenylketonuria (“PKU”), achieved its primary endpoint of reduction in blood phenylalanine (“Phe”) levels.
Data from the APHENITY study showed that patients who were treated with sepiapterin achieved a mean blood Phe reduction of 63%. These results were statistically significant when compared to those patients who were administered placebo, demonstrating the drug’s treatment benefits.
Based on the above data, management will begin discussions with regulatory authorities to discuss the path for a potential regulatory approval.
In the year so far, shares of PTC Therapeutics have surged 52.7% against the industry’s 1.0% fall.
Image Source: Zacks Investment Research
PKU is a rare genetic enzyme deficiency disorder, caused by defect in the gene that help creates the enzyme needed to break down Phe. If left untreated, a build-up of Phe can lead to severe and irreversible disabilities, like permanent intellectual disability, seizures, delayed development, memory loss and behavioral and emotional problems. Per management, nearly 58,000 people across the globe suffer from PKU.
If sepiapterin were to be approved, it would face stiff competition from BioMarin Pharmaceuticals (BMRN - Free Report) , which already markets medications in the PKU space. BioMarin’s portfolio consists of two medications, namely Kuvan and Palynziq, which are approved by the FDA to lower blood Phe levels in a certain type of PKU. Currently, BioMarin is facing generic erosion for Kuvan in the United States, hurting its topline significantly.
PTC Therapeutics, Inc. Price
PTC Therapeutics, Inc. price | PTC Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
PTC Therapeutics currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include ANI Pharmaceuticals (ANIP - Free Report) and Allogene Therapeutics (ALLO - Free Report) . While ANI Pharmaceuticals sports a Zacks Rank #1 (Strong Buy), Allogene carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2023 earnings per share have increased from $2.42 to $3.31. During the same period, the earnings estimates per share for 2024 have risen from $3.76 to $4.32. Shares of ANI Pharmaceuticals are up 10.6% in the year-to-date period.
Earnings of ANIP Pharmaceuticals beat estimates in each of the last four quarters, delivering an average earnings surprise of 68.64%. In the last reported quarter, ANI Pharmaceuticals’ earnings beat estimates by 244.12%.
In the past 60 days, estimates for Allogene Therapeutics’ 2023 loss per share have improved from $2.50 to $2.32. During the same period, the loss estimates per share for 2024 have narrowed from $2.48 to $2.21. Shares of Allogene Therapeutics have declined 2.7% in the year-to-date period.
Earnings of Allogene Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a surprise of 5.08%. In the last reported quarter, Allogene Therapeutics’ earnings beat estimates by 7.94%.